The FDA’s Adverse Event Reporting Requirements

The adverse event reporting system is an important highlight of the FDA’s adverse event reporting requirements. This is the mechanism through which adverse event reporting requirements are listed out for the FDA to take further action. The adverse event reporting system may be understood as being a database that aids and supplements the FDA’s postmarketing […]

It is important and necessary to document Software for FDA Submissions

Software project management has an important tool in the Agile methodology. The Agile methodology developed as a product of the gradual efforts at arriving at a team based methodology of iterative software development. Because of its close association with software, in terms of suitability; Agile is to software development what Lean is to manufacturing. Among […]